Label: FERMIERPAPA PURE MORINGA SUNSCREEN- zinc oxide, titanium dioxide cream

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated February 1, 2021

If you are a consumer or patient please visit this version.

  • ACTIVE INGREDIENTS

    Zinc Oxide 10.26%
    Titanium Dioxide 6.00%

  • INACTIVE INGREDIENTS

    Moringa Oleifera Leaf Extract, Dicaprylyl Carbonate, Coco-Caprylate/Caprate, Caprylic/Capric Triglyceride,Propanediol,Pentylene Glycol, Polyglyceryl-3 , Polyricinoleate, Cocos Nucifera (Coconut) Oil, Stearic Acid, Dicaprylyl Ether, Aloe Barbadensis Leaf Water, Beeswax, Euphorbia Cerifera (Candelilla) , Wax, Sodium Chloride, Aluminum Hydroxide,Polyglyceryl-2 , Dipolyhydroxystearate, Glyceryl Caprylate, Helianthus Annuus (Sunflower) Seed Oil, Polyglyceryl-3 Diisostearate, Simmondsia Chinensis (Jojoba) Seed Oil, Polyglyceryl-3 Ricinoleate, Butylene Glycol, Water, Cucurbita Pepo (Pumpkin) Seed Oil, Houttuynia Cordata Extract, Sodium Gluconate, Xanthan Gum, Dipotassium Glycyrrhizate, Centella Asiatica Extract, Lavandula Angustifolia (Lavender) Oil, Polygonum Cuspidatum Root Extract, Scutellaria Baicalensis Root Extract, Camellia Sinensis Leaf Extract, Glycyrrhiza Uralensis (Licorice) Root Extract, Chamomilla Recutita (Matricaria) Flower Extract, Rosmarinus Officinalis (Rosemary) Leaf Extract

  • PURPOSE

    Sunscreen

  • WARNINGS

    For external use only
    Avoid contact with eyes.
    Recommend to use it after small amounts are tested on your skin.
    Discontinue use if signs of irritation or rashes appear.
    Replace the cap after use.
    Do not use on the part having scars.
    Keep it by avoiding direct sunlight.
    Keep out of reach of children

  • DESCRIPTION

    Uses
    ■ Helps prevent sunburn.
    ■ Prevention of freckles and blemishes
    ■ Skin aging prevention
    ■ Prevention of skin cancer, etc.

    Directions
    ■ Apply on all exposed areas 15-20 minutes before sun exposure.
    ■ Re-apply often (every 2 hours) and after swimming, excessive perspiration and washing to ensure maximum sun protection.
    ■ In case of staying long hours outside, apply it every 3 hours.
    apply small amount to the skin evenly to be exposed to UV rays before you go out.
    ■ Soak the cotton pad with sunscreen remover and wipe the part softly the sunscreen is applied. Then rinse off it with a foam cleanser like doing massage
    ■ In case of staying long hours outside, apply it every 3 hours.

    Questions
    070-7807-7800
    https://fermierpapa.com

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    Image of carton

  • INGREDIENTS AND APPEARANCE
    FERMIERPAPA PURE MORINGA SUNSCREEN 
    zinc oxide, titanium dioxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:81482-010
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Zinc Oxide (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION5.13 g  in 50 g
    Titanium Dioxide (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) Titanium Dioxide3.00 g  in 50 g
    Inactive Ingredients
    Ingredient NameStrength
    MORINGA OLEIFERA LEAF (UNII: 4WET1AWO9B)  
    Dicaprylyl Carbonate (UNII: 609A3V1SUA)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:81482-010-021 in 1 CARTON01/02/2021
    1NDC:81482-010-0150 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35201/02/2021
    Labeler - Cheolwon Cosmetic Farming Association (694697125)
    Registrant - Cheolwon Cosmetic Farming Association (694697125)
    Establishment
    NameAddressID/FEIBusiness Operations
    Cheolwon Cosmetic Farming Association694697125manufacture(81482-010)